← Trials/Trial dossier/NCT00518115
CompletedPhase 2Results posted
Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only
A 16-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of Multiple Doses and Multiple Treatment Regimens of GSK716155, With Byetta as an Open Label Active Reference, in Subjects With Type 2 Diabetes Mellitus
Lead sponsor
Assets
Albiglutide / Exenatide
Listed sites
163
Recruiting sites
—
Enrollment
361
actual
Study population
Type 2 diabetes
Key I/E criteria
•BMI 20-40•HbA1c 7-10%
Primary endpoint
•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
NCT IDNCT00518115
Org study IDGLP110125
Timeline
Milestones
Study first posted2007-08-20estimated
Results first posted2014-06-23estimated
Last update posted2016-12-16estimated
Study start2007-04 (month precision)
Primary completion2008-05actual (month precision)
Study completion2008-05actual (month precision)
Assets
Investigational agents
Study populations
Who this study enrolls
Type 2 diabetes
Eligibility
Who can enroll
Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted
Inclusion criteria
•Has type 2 diabetes mellitus as defined by the criteria of the American Diabetes Association and recognized by World Health Organization Expert Committee on the Diagnosis and Classification of Diabetes Mellitus [American Diabetes Association, 2004a] at least three months preceding screening
•Has concurrent type 2 diabetes mellitus therapy: Must be diet and exercise treated; must not have taken antidiabetic medication for at least three months prior to prescreening or Monotherapy with metformin, with a history of a stable dose for at least three months before prescreening (not taking more than one oral antidiabetic agent)
•Has HbA1c level at screening ≥7 and ≤10%
•Is male or female 18 to 75 years of age, inclusive, at screening
•Has body mass index ≥20 and ≤40 kg/m²
•If subject is a smoker, must be able to abstain while in clinic at each visit
•If female, is eligible to enter and participate throughout the study, including the follow-up period: 1) If of nonchildbearing potential (i.e. physiologically incapable of becoming pregnant {tubal ligation}, including any female who is postmenopausal [>1 year without menstrual period]); or, 2) If of childbearing potential, has negative pregnancy tests at screening (serum) and at baseline (urine) and: 3) Has a male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject, or 4) Uses double-barrier methods of contraception; condoms (with spermicide) and intrauterine devices are acceptable, or 5) Uses hormonal contraceptives (oral, depots, patches, etc) with double-barrier methods of contraception as outlined above, or, 6) Abstains from sexual intercourse, or 7) Is with a same-sex partner and does not participate in bisexual activities where there is any risk of pregnancy
•Signs and dates informed consent before any study-related procedures are performed
Exclusion criteria
•Has metabolic disease including but not limited to: 1) Diagnosis of type 1 diabetes mellitus, 2) Uncorrected thyroid dysfunction (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy for at least three months prior to screening, and who have a screening thyroid-stimulating hormone within the limits of normal may participate)
•Has qualitative changes in lifestyle that, in the opinion of the investigator, would affect the subject's weight or disease status
•Had previous use of insulin within one month prior to screening, or more than seven total days of insulin treatment within three months prior to screening
•Has clinically significant cardiovascular and/or cerebrovascular disease including, but not limited to: 1) Previous history of stroke or transient ischemic attack, 2) Active, unstable coronary heart disease within the past six months, 3) Documented myocardial infarction within a year prior to screening 4) Any cardiac surgery including percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery within a year prior to screening 5) Unstable angina 6) Clinically significant arrhythmia or valvular heart disease within the past year 7) Congestive heart failure with New York Heart Association Class II to Class IV symptoms. Class I is acceptable. 8) Untreated hypertension, with systolic pressure greater than 160mm Hg and/or diastolic pressure greater than 95mm Hg. 9) ECG exclusion criteria: Heart rate is <40 and >110 beats per minute, PR Interval is <120 and >210msec, QRS duration is <70 and >120msec, QTc interval (Bazett) is >450msec or >480msec with bundle branch block
•Has fasting serum triglycerides ≥800mg/dL or 9mmol/L at screening (Visit 2). Subjects receiving lipid-lowering therapy must have been on the same dose of therapy for the past three months. Fasting is defined as no food/drink for at least eight hours prior to sampling
•If female, is currently lactating, pregnant, or actively trying to become pregnant
•Has significant renal disease as manifested by one or more of the following: 1) Creatinine clearance <60mL/min. (estimated from serum creatinine and demographic data using the modification of diet in renal disease calculation; refer to the SPM/ISFM), 2) Urine albumin excretion ≥500 µg/mL on a urine spot check, 3) Known loss of a kidney either by surgical ablation, injury, or disease
•Has history of significant comorbid diseases active within the last six months (e.g., gastrointestinal disease)
•Has history of pancreatitis within five years prior to randomization
•Has a documented history of chronic or advanced hepatobiliary disease including a history of, or positive laboratory results for, hepatitis at screening (Visit 2), and/or clinically significant hepatic enzyme elevation including: 1) Any two of the following enzymes greater than 1.5 times the upper limit of normal (ULN) value: - alanine aminotransferase (ALT), - aspartate aminotransferase (AST), - alkaline phosphatase (ALP), 2) Any one of the above enzymes two times greater than the ULN value AND total or direct bilirubin >1.5 times the ULN
•Has a history of alcohol or substance abuse within the past year, as determined by the investigator or a positive urine drug screen at screening (Visit 2) or during treatment: 1) Unwilling to refrain from the use of excessive alcohol or illicit drugs and adhere to other protocol-stated restrictions while participating in the study, 2) History of alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than two units (females). One unit is equivalent to a half-pint of beer or one measure of spirits or one glass of wine, 2) The investigator should exercise their medical judgment to determine if a urine drug screen is indicated
•Is currently taking prohibited concomitant medications listed in Section 6.6.2
•Has clinically significant anemia (i.e., hemoglobin <12.0g/dL or <120.0g/L for males and <11.0g/dL or <110.0g/L for females) or any other abnormal hematological profile that is considered by the investigator to be clinically significant
•Has known allergy to any formulation excipients, or history of drug or other allergy, which, in the opinion of the responsible study physician, contradicts participation
•Received treatment with an investigational drug or participated in any other clinical trial during the previous 30 days
•Has prior use of investigational agents with long half-lives of greater than seven days within the three months prior to screening
•Has any prior use of a GLP-1 analog, including GSK716155
•In the opinion of the investigator, has a risk of noncompliance with study procedures, or cannot read, understand, or complete study-related materials, particularly the informed consent
•Has any concurrent condition or any clinically significant abnormality identified on the screening physical examination, laboratory tests, ECG, including pulmonary, neurological, or inflammatory diseases, which, in the opinion of the investigator, may affect the interpretation of efficacy and safety data, or which otherwise, contraindicates participation in a clinical trial with a new chemical entity
Endpoints (18)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Glycemic / diabetes
8
Safety / tolerability / PK
4
Weight & body composition
3
Patient-reported / QoL
2
Cardiometabolic biomarkers
1
Weight & body composition
3 endpointsSecondary/protocol endpoint
Change From Baseline in Waist Circumference at Week 16
Time frame:Baseline and Week 16
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Value (mean), Centimeters | 95% CI |
|---|---|---|
| Placebo | -0.51 | — |
| Exenatide BID | -3.53 | — |
| Albiglutide 4 mg Weekly | -1.50 | — |
| Albiglutide 15 mg Weekly | -3.16 | — |
| Albiglutide 30 mg Weekly | -1.14 | — |
| Albiglutide 15 mg Bi-weekly | -1.83 | — |
| Albiglutide 30 mg Bi-weekly | -0.47 | — |
| Albiglutide 50 mg Bi-weekly | -2.00 | — |
| Albiglutide 50 mg Every 4 Weeks | -0.88 | — |
| Albiglutide 100 mg Every 4 Weeks | -0.77 | — |
Secondary/protocol endpoint
Change From Baseline in Body Weight at Week 16
Time frame:Baseline and Week 16
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), Kilograms (Kg) | 95% CI |
|---|---|---|
| Placebo | -0.71 | — |
| Exenatide BID | -2.41 | — |
| Albiglutide 4 mg Weekly | -0.91 | — |
| Albiglutide 15 mg Weekly | -0.90 | — |
| Albiglutide 30 mg Weekly | -1.43 | — |
| Albiglutide 15 mg Bi-weekly | -1.76 | — |
| Albiglutide 30 mg Bi-weekly | -1.59 | — |
| Albiglutide 50 mg Bi-weekly | -1.14 | — |
| Albiglutide 50 mg Every 4 Weeks | -1.08 | — |
| Albiglutide 100 mg Every 4 Weeks | -1.65 | — |
Secondary/protocol endpoint
Percent Change From Baseline in Body Weight at Week 16
Time frame:Baseline and Week 16
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Value (mean), Percent change | 95% CI |
|---|---|---|
| Placebo | -0.72 | — |
| Exenatide BID | -2.53 | — |
| Albiglutide 4 mg Weekly | -0.94 | — |
| Albiglutide 15 mg Weekly | -1.04 | — |
| Albiglutide 30 mg Weekly | -1.59 | — |
| Albiglutide 15 mg Bi-weekly | -1.97 | — |
| Albiglutide 30 mg Bi-weekly | -1.69 | — |
| Albiglutide 50 mg Bi-weekly | -1.32 | — |
| Albiglutide 50 mg Every 4 Weeks | -1.37 | — |
| Albiglutide 100 mg Every 4 Weeks | -1.89 | — |
Glycemic / diabetes
8 endpointsPrimary/protocol endpoint
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16
Time frame:Baseline and Week 16
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (least_squares_mean), Percentage of HbA1c in the blood | 95% CI |
|---|---|---|
| Placebo | -0.46 | — |
| Albiglutide 4 mg Weekly | -0.25 | — |
| Albiglutide 15 mg Weekly | -0.71 | — |
| Albiglutide 30 mg Weekly | -1.08 | — |
| Albiglutide 15 mg Bi-weekly | -0.68 | — |
| Albiglutide 30 mg Bi-weekly | -1.01 | — |
| Albiglutide 50 mg Bi-weekly | -1.03 | — |
| Albiglutide 50 mg Every 4 Weeks | -0.80 | — |
| Albiglutide 100 mg Every 4 Weeks | -1.06 | — |
Mean Difference (Final Values)0.2095% CI-0.18 – 0.59p0.2968ANCOVA
Mean Difference (Final Values)-0.2695% CI-0.64 – 0.12p0.1860ANCOVA
Mean Difference (Final Values)-0.6295% CI-1.03 – -0.22p0.0027ANCOVA
Mean Difference (Final Values)-0.2295% CI-0.62 – 0.18p0.2766ANCOVA
Mean Difference (Final Values)-0.5595% CI-0.94 – -0.16p0.0057ANCOVA
Mean Difference (Final Values)-0.5795% CI-0.96 – -0.19p0.0032ANCOVA
Mean Difference (Final Values)-0.3495% CI-0.72 – 0.04p0.0786ANCOVA
Mean Difference (Final Values)-0.6095% CI-0.99 – -0.22p0.0022ANCOVA
Secondary/protocol endpoint
Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Time frame:Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), Percentage of HbA1c in the blood | 95% CI |
|---|---|---|
| PlaceboWeek 4, n=47,34,33,34,28,29,31,34,34,30 | -0.14 | — |
| Week 5, n=49,34,34,34,29,30,32,34,35,31 | -0.09 | — |
| Week 7, n=50,34,34,34,29,30,32,34,35,32 | -0.15 | — |
| Week 8, n=50,34,34,34,29,30,32,34,35,32 | -0.17 | — |
| Week 9, n=50,34,34,34,29,30,32,34,35,32 | -0.21 | — |
| Week 12, n=50,34,34,34,29,30,32,34,35,33 | -0.19 | — |
| Week 15, n=50,34,34,34,29,30,32,34,35,33 | -0.27 | — |
| Week 16, n=50,34,34,34,29,30,32,34,35,33 | -0.17 | — |
| Exenatide BIDWeek 4, n=47,34,33,34,28,29,31,34,34,30 | -0.23 | — |
| Week 5, n=49,34,34,34,29,30,32,34,35,31 | -0.32 | — |
| Week 7, n=50,34,34,34,29,30,32,34,35,32 | -0.36 | — |
| Week 8, n=50,34,34,34,29,30,32,34,35,32 | -0.45 | — |
| Week 9, n=50,34,34,34,29,30,32,34,35,32 | -0.51 | — |
| Week 12, n=50,34,34,34,29,30,32,34,35,33 | -0.56 | — |
| Week 15, n=50,34,34,34,29,30,32,34,35,33 | -0.53 | — |
| Week 16, n=50,34,34,34,29,30,32,34,35,33 | -0.54 | — |
| Albiglutide 4 mg WeeklyWeek 4, n=47,34,33,34,28,29,31,34,34,30 | -0.12 | — |
| Week 5, n=49,34,34,34,29,30,32,34,35,31 | -0.16 | — |
| Week 7, n=50,34,34,34,29,30,32,34,35,32 | -0.19 | — |
| Week 8, n=50,34,34,34,29,30,32,34,35,32 | -0.24 | — |
| Week 9, n=50,34,34,34,29,30,32,34,35,32 | -0.19 | — |
| Week 12, n=50,34,34,34,29,30,32,34,35,33 | -0.18 | — |
| Week 15, n=50,34,34,34,29,30,32,34,35,33 | -0.19 | — |
| Week 16, n=50,34,34,34,29,30,32,34,35,33 | -0.11 | — |
| Albiglutide 15 mg WeeklyWeek 4, n=47,34,33,34,28,29,31,34,34,30 | -0.33 | — |
| Week 5, n=49,34,34,34,29,30,32,34,35,31 | -0.39 | — |
| Week 7, n=50,34,34,34,29,30,32,34,35,32 | -0.44 | — |
| Week 8, n=50,34,34,34,29,30,32,34,35,32 | -0.50 | — |
| Week 9, n=50,34,34,34,29,30,32,34,35,32 | -0.55 | — |
| Week 12, n=50,34,34,34,29,30,32,34,35,33 | -0.58 | — |
| Week 15, n=50,34,34,34,29,30,32,34,35,33 | -0.49 | — |
| Week 16, n=50,34,34,34,29,30,32,34,35,33 | -0.49 | — |
| Albiglutide 30 mg WeeklyWeek 4, n=47,34,33,34,28,29,31,34,34,30 | -0.56 | — |
| Week 5, n=49,34,34,34,29,30,32,34,35,31 | -0.62 | — |
| Week 7, n=50,34,34,34,29,30,32,34,35,32 | -0.79 | — |
| Week 8, n=50,34,34,34,29,30,32,34,35,32 | -0.77 | — |
| Week 9, n=50,34,34,34,29,30,32,34,35,32 | -0.85 | — |
| Week 12, n=50,34,34,34,29,30,32,34,35,33 | -0.96 | — |
| Week 15, n=50,34,34,34,29,30,32,34,35,33 | -0.86 | — |
| Week 16, n=50,34,34,34,29,30,32,34,35,33 | -0.87 | — |
| Albiglutide 15 mg Bi-weeklyWeek 4, n=47,34,33,34,28,29,31,34,34,30 | -0.35 | — |
| Week 5, n=49,34,34,34,29,30,32,34,35,31 | -0.42 | — |
| Week 7, n=50,34,34,34,29,30,32,34,35,32 | -0.52 | — |
| Week 8, n=50,34,34,34,29,30,32,34,35,32 | -0.54 | — |
| Week 9, n=50,34,34,34,29,30,32,34,35,32 | -0.56 | — |
| Week 12, n=50,34,34,34,29,30,32,34,35,33 | -0.59 | — |
| Week 15, n=50,34,34,34,29,30,32,34,35,33 | -0.61 | — |
| Week 16, n=50,34,34,34,29,30,32,34,35,33 | -0.56 | — |
| Albiglutide 30 mg Bi-weeklyWeek 4, n=47,34,33,34,28,29,31,34,34,30 | -0.34 | — |
| Week 5, n=49,34,34,34,29,30,32,34,35,31 | -0.51 | — |
| Week 7, n=50,34,34,34,29,30,32,34,35,32 | 0.64 | — |
| Week 8, n=50,34,34,34,29,30,32,34,35,32 | -0.67 | — |
| Week 9, n=50,34,34,34,29,30,32,34,35,32 | -0.71 | — |
| Week 12, n=50,34,34,34,29,30,32,34,35,33 | -0.71 | — |
| Week 15, n=50,34,34,34,29,30,32,34,35,33 | -0.79 | — |
| Week 16, n=50,34,34,34,29,30,32,34,35,33 | -0.79 | — |
| Albiglutide 50 mg Bi-weeklyWeek 4, n=47,34,33,34,28,29,31,34,34,30 | -0.45 | — |
| Week 5, n=49,34,34,34,29,30,32,34,35,31 | -0.58 | — |
| Week 7, n=50,34,34,34,29,30,32,34,35,32 | -0.68 | — |
| Week 8, n=50,34,34,34,29,30,32,34,35,32 | -0.71 | — |
| Week 9, n=50,34,34,34,29,30,32,34,35,32 | -0.77 | — |
| Week 12, n=50,34,34,34,29,30,32,34,35,33 | -0.79 | — |
| Week 15, n=50,34,34,34,29,30,32,34,35,33 | -0.80 | — |
| Week 16, n=50,34,34,34,29,30,32,34,35,33 | -0.79 | — |
| Albiglutide 50 mg Every 4 WeeksWeek 4, n=47,34,33,34,28,29,31,34,34,30 | -0.41 | — |
| Week 5, n=49,34,34,34,29,30,32,34,35,31 | -0.47 | — |
| Week 7, n=50,34,34,34,29,30,32,34,35,32 | -0.45 | — |
| Week 8, n=50,34,34,34,29,30,32,34,35,32 | -0.41 | — |
| Week 9, n=50,34,34,34,29,30,32,34,35,32 | -0.54 | — |
| Week 12, n=50,34,34,34,29,30,32,34,35,33 | -0.51 | — |
| Week 15, n=50,34,34,34,29,30,32,34,35,33 | -0.58 | — |
| Week 16, n=50,34,34,34,29,30,32,34,35,33 | -0.55 | — |
| Albiglutide 100 mg Every 4 WeeksWeek 4, n=47,34,33,34,28,29,31,34,34,30 | -0.42 | — |
| Week 5, n=49,34,34,34,29,30,32,34,35,31 | -0.65 | — |
| Week 7, n=50,34,34,34,29,30,32,34,35,32 | -0.63 | — |
| Week 8, n=50,34,34,34,29,30,32,34,35,32 | -0.68 | — |
| Week 9, n=50,34,34,34,29,30,32,34,35,32 | -0.82 | — |
| Week 12, n=50,34,34,34,29,30,32,34,35,33 | -0.84 | — |
| Week 15, n=50,34,34,34,29,30,32,34,35,33 | -0.88 | — |
| Week 16, n=50,34,34,34,29,30,32,34,35,33 | -0.87 | — |
Secondary/protocol endpoint
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Time frame:Weeks (W) 4, 5, 7, 8, 9, 12, 15, and 16
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Value (number), Participants | 95% CI |
|---|---|---|
| PlaceboW4: <6.5%, n=47,34,33,34,28,29,31,34,34,30 | 1 | — |
| W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,30 | 8 | — |
| W5: <6.5%, n=49,34,34,34,29,30,32,34,35,31 | 2 | — |
| W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,31 | 4 | — |
| W7: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 1 | — |
| W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 9 | — |
| W8: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 1 | — |
| W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 10 | — |
| W9: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 3 | — |
| W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 9 | — |
| W12: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 3 | — |
| W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 7 | — |
| W15: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 3 | — |
| W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 8 | — |
| W16: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 2 | — |
| W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 8 | — |
| Exenatide BIDW4: <6.5%, n=47,34,33,34,28,29,31,34,34,30 | 0 | — |
| W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,30 | 5 | — |
| W5: <6.5%, n=49,34,34,34,29,30,32,34,35,31 | 0 | — |
| W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,31 | 7 | — |
| W7: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 1 | — |
| W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 9 | — |
| W8: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 2 | — |
| W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 7 | — |
| W9: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 2 | — |
| W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 9 | — |
| W12: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 3 | — |
| W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 8 | — |
| W15: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 4 | — |
| W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 6 | — |
| W16: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 4 | — |
| W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 8 | — |
| Albiglutide 4 mg WeeklyW4: <6.5%, n=47,34,33,34,28,29,31,34,34,30 | 0 | — |
| W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,30 | 5 | — |
| W5: <6.5%, n=49,34,34,34,29,30,32,34,35,31 | 1 | — |
| W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,31 | 5 | — |
| W7: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 1 | — |
| W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 4 | — |
| W8: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 1 | — |
| W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 6 | — |
| W9: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 2 | — |
| W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 5 | — |
| W12: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 2 | — |
| W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 4 | — |
| W15: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 2 | — |
| W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 5 | — |
| W16: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 3 | — |
| W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 3 | — |
| Albiglutide 15 mg WeeklyW4: <6.5%, n=47,34,33,34,28,29,31,34,34,30 | 1 | — |
| W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,30 | 8 | — |
| W5: <6.5%, n=49,34,34,34,29,30,32,34,35,31 | 2 | — |
| W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,31 | 7 | — |
| W7: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 4 | — |
| W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 4 | — |
| W8: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 4 | — |
| W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 8 | — |
| W9: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 6 | — |
| W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 7 | — |
| W12: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 5 | — |
| W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 8 | — |
| W15: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 4 | — |
| W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 8 | — |
| W16: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 4 | — |
| W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 8 | — |
| Albiglutide 30 mg WeeklyW4: <6.5%, n=47,34,33,34,28,29,31,34,34,30 | 4 | — |
| W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,30 | 8 | — |
| W5: <6.5%, n=49,34,34,34,29,30,32,34,35,31 | 4 | — |
| W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,31 | 8 | — |
| W7: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 8 | — |
| W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 5 | — |
| W8: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 6 | — |
| W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 8 | — |
| W9: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 8 | — |
| W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 5 | — |
| W12: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 11 | — |
| W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 5 | — |
| W15: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 8 | — |
| W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 7 | — |
| W16: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 10 | — |
| W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 5 | — |
| Albiglutide 15 mg Bi-weeklyW4: <6.5%, n=47,34,33,34,28,29,31,34,34,30 | 0 | — |
| W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,30 | 6 | — |
| W5: <6.5%, n=49,34,34,34,29,30,32,34,35,31 | 1 | — |
| W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,31 | 5 | — |
| W7: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 1 | — |
| W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 9 | — |
| W8: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 1 | — |
| W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 9 | — |
| W9: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 1 | — |
| W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 10 | — |
| W12: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 3 | — |
| W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 7 | — |
| W15: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 4 | — |
| W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 7 | — |
| W16: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 5 | — |
| W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 3 | — |
| Albiglutide 30 mg Bi-weeklyW4: <6.5%, n=47,34,33,34,28,29,31,34,34,30 | 0 | — |
| W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,30 | 8 | — |
| W5: <6.5%, n=49,34,34,34,29,30,32,34,35,31 | 1 | — |
| W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,31 | 9 | — |
| W7: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 3 | — |
| W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 11 | — |
| W8: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 4 | — |
| W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 12 | — |
| W9: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 3 | — |
| W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 11 | — |
| W12: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 3 | — |
| W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 13 | — |
| W15: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 6 | — |
| W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 8 | — |
| W16: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 4 | — |
| W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 12 | — |
| Albiglutide 50 mg Bi-weeklyW4: <6.5%, n=47,34,33,34,28,29,31,34,34,30 | 3 | — |
| W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,30 | 5 | — |
| W5: <6.5%, n=49,34,34,34,29,30,32,34,35,31 | 2 | — |
| W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,31 | 11 | — |
| W7: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 6 | — |
| W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 9 | — |
| W8: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 7 | — |
| W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 10 | — |
| W9: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 7 | — |
| W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 10 | — |
| W12: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 8 | — |
| W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 11 | — |
| W15: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 10 | — |
| W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 9 | — |
| W16: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 10 | — |
| W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 8 | — |
| Albiglutide 50 mg Every 4 WeeksW4: <6.5%, n=47,34,33,34,28,29,31,34,34,30 | 1 | — |
| W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,30 | 6 | — |
| W5: <6.5%, n=49,34,34,34,29,30,32,34,35,31 | 1 | — |
| W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,31 | 7 | — |
| W7: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 2 | — |
| W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 8 | — |
| W8: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 2 | — |
| W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 4 | — |
| W9: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 2 | — |
| W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 9 | — |
| W12: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 2 | — |
| W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 9 | — |
| W15: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 3 | — |
| W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 8 | — |
| W16: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 3 | — |
| W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 5 | — |
| Albiglutide 100 mg Every 4 WeeksW4: <6.5%, n=47,34,33,34,28,29,31,34,34,30 | 3 | — |
| W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,30 | 6 | — |
| W5: <6.5%, n=49,34,34,34,29,30,32,34,35,31 | 4 | — |
| W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,31 | 12 | — |
| W7: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 5 | — |
| W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 8 | — |
| W8: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 5 | — |
| W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 11 | — |
| W9: <6.5%, n=50,34,34,34,29,30,32,34,35,32 | 9 | — |
| W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32 | 8 | — |
| W12: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 7 | — |
| W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 8 | — |
| W15: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 9 | — |
| W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 7 | — |
| W16: <6.5%, n=50,34,34,34,29,30,32,34,35,33 | 8 | — |
| W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33 | 8 | — |
Secondary/protocol endpoint
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Time frame:Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), Millimoles per liter (mmol/L) | 95% CI |
|---|---|---|
| PlaceboWeek 4, n=47,33,32,32,29,28,32,32,34,32 | -0.40 | — |
| Week 5, n=47,33,32,32,29,28,32,32,34,32 | -0.40 | — |
| Week 7, n=47,33,32,32,29,28,32,32,34,33 | -0.19 | — |
| Week 8, n=47,33,32,32,29,28,32,32,34,33 | -0.44 | — |
| Week 9, n=47,33,32,32,29,28,32,32,34,33 | -0.25 | — |
| Week 12, n=47,33,32,32,29,28,32,32,34,33 | -0.27 | — |
| Week 15, n=47,33,32,32,29,28,32,32,34,33 | -0.44 | — |
| Week 16, n=47,33,32,32,29,28,32,32,34,33 | -0.10 | — |
| Exenatide BIDWeek 4, n=47,33,32,32,29,28,32,32,34,32 | -1.11 | — |
| Week 5, n=47,33,32,32,29,28,32,32,34,32 | -1.06 | — |
| Week 7, n=47,33,32,32,29,28,32,32,34,33 | -1.25 | — |
| Week 8, n=47,33,32,32,29,28,32,32,34,33 | -1.43 | — |
| Week 9, n=47,33,32,32,29,28,32,32,34,33 | -1.54 | — |
| Week 12, n=47,33,32,32,29,28,32,32,34,33 | -1.32 | — |
| Week 15, n=47,33,32,32,29,28,32,32,34,33 | -1.27 | — |
| Week 16, n=47,33,32,32,29,28,32,32,34,33 | -0.80 | — |
| Albiglutide 4 mg WeeklyWeek 4, n=47,33,32,32,29,28,32,32,34,32 | -0.99 | — |
| Week 5, n=47,33,32,32,29,28,32,32,34,32 | -1.02 | — |
| Week 7, n=47,33,32,32,29,28,32,32,34,33 | -0.80 | — |
| Week 8, n=47,33,32,32,29,28,32,32,34,33 | -1.22 | — |
| Week 9, n=47,33,32,32,29,28,32,32,34,33 | -1.13 | — |
| Week 12, n=47,33,32,32,29,28,32,32,34,33 | -1.04 | — |
| Week 15, n=47,33,32,32,29,28,32,32,34,33 | -0.67 | — |
| Week 16, n=47,33,32,32,29,28,32,32,34,33 | -0.47 | — |
| Albiglutide 15 mg WeeklyWeek 4, n=47,33,32,32,29,28,32,32,34,32 | -0.58 | — |
| Week 5, n=47,33,32,32,29,28,32,32,34,32 | -1.05 | — |
| Week 7, n=47,33,32,32,29,28,32,32,34,33 | -0.13 | — |
| Week 8, n=47,33,32,32,29,28,32,32,34,33 | -0.80 | — |
| Week 9, n=47,33,32,32,29,28,32,32,34,33 | -0.71 | — |
| Week 12, n=47,33,32,32,29,28,32,32,34,33 | -0.70 | — |
| Week 15, n=47,33,32,32,29,28,32,32,34,33 | -0.70 | — |
| Week 16, n=47,33,32,32,29,28,32,32,34,33 | -0.72 | — |
| Albiglutide 30 mg WeeklyWeek 4, n=47,33,32,32,29,28,32,32,34,32 | -1.39 | — |
| Week 5, n=47,33,32,32,29,28,32,32,34,32 | -1.53 | — |
| Week 7, n=47,33,32,32,29,28,32,32,34,33 | -1.54 | — |
| Week 8, n=47,33,32,32,29,28,32,32,34,33 | -1.60 | — |
| Week 9, n=47,33,32,32,29,28,32,32,34,33 | -1.49 | — |
| Week 12, n=47,33,32,32,29,28,32,32,34,33 | -1.85 | — |
| Week 15, n=47,33,32,32,29,28,32,32,34,33 | -1.54 | — |
| Week 16, n=47,33,32,32,29,28,32,32,34,33 | -1.44 | — |
| Albiglutide 15 mg Bi-weeklyWeek 4, n=47,33,32,32,29,28,32,32,34,32 | -1.06 | — |
| Week 5, n=47,33,32,32,29,28,32,32,34,32 | -1.41 | — |
| Week 7, n=47,33,32,32,29,28,32,32,34,33 | -1.16 | — |
| Week 8, n=47,33,32,32,29,28,32,32,34,33 | -1.29 | — |
| Week 9, n=47,33,32,32,29,28,32,32,34,33 | -1.29 | — |
| Week 12, n=47,33,32,32,29,28,32,32,34,33 | -1.11 | — |
| Week 15, n=47,33,32,32,29,28,32,32,34,33 | -1.45 | — |
| Week 16, n=47,33,32,32,29,28,32,32,34,33 | -1.28 | — |
| Albiglutide 30 mg Bi-weeklyWeek 4, n=47,33,32,32,29,28,32,32,34,32 | -0.97 | — |
| Week 5, n=47,33,32,32,29,28,32,32,34,32 | -1.72 | — |
| Week 7, n=47,33,32,32,29,28,32,32,34,33 | -1.51 | — |
| Week 8, n=47,33,32,32,29,28,32,32,34,33 | -1.27 | — |
| Week 9, n=47,33,32,32,29,28,32,32,34,33 | -1.64 | — |
| Week 12, n=47,33,32,32,29,28,32,32,34,33 | -1.57 | — |
| Week 15, n=47,33,32,32,29,28,32,32,34,33 | -1.71 | — |
| Week 16, n=47,33,32,32,29,28,32,32,34,33 | -1.58 | — |
| Albiglutide 50 mg Bi-weeklyWeek 4, n=47,33,32,32,29,28,32,32,34,32 | -1.35 | — |
| Week 5, n=47,33,32,32,29,28,32,32,34,32 | -2.17 | — |
| Week 7, n=47,33,32,32,29,28,32,32,34,33 | -1.87 | — |
| Week 8, n=47,33,32,32,29,28,32,32,34,33 | -1.29 | — |
| Week 9, n=47,33,32,32,29,28,32,32,34,33 | -1.68 | — |
| Week 12, n=47,33,32,32,29,28,32,32,34,33 | -1.49 | — |
| Week 15, n=47,33,32,32,29,28,32,32,34,33 | -1.66 | — |
| Week 16, n=47,33,32,32,29,28,32,32,34,33 | -1.32 | — |
| Albiglutide 50 mg Every 4 WeeksWeek 4, n=47,33,32,32,29,28,32,32,34,32 | -0.14 | — |
| Week 5, n=47,33,32,32,29,28,32,32,34,32 | -1.55 | — |
| Week 7, n=47,33,32,32,29,28,32,32,34,33 | -0.41 | — |
| Week 8, n=47,33,32,32,29,28,32,32,34,33 | -0.66 | — |
| Week 9, n=47,33,32,32,29,28,32,32,34,33 | -1.48 | — |
| Week 12, n=47,33,32,32,29,28,32,32,34,33 | -0.49 | — |
| Week 15, n=47,33,32,32,29,28,32,32,34,33 | -0.79 | — |
| Week 16, n=47,33,32,32,29,28,32,32,34,33 | -0.72 | — |
| Albiglutide 100 mg Every 4 WeeksWeek 4, n=47,33,32,32,29,28,32,32,34,32 | -0.61 | — |
| Week 5, n=47,33,32,32,29,28,32,32,34,32 | -2.12 | — |
| Week 7, n=47,33,32,32,29,28,32,32,34,33 | -1.07 | — |
| Week 8, n=47,33,32,32,29,28,32,32,34,33 | -1.29 | — |
| Week 9, n=47,33,32,32,29,28,32,32,34,33 | -2.25 | — |
| Week 12, n=47,33,32,32,29,28,32,32,34,33 | -1.50 | — |
| Week 15, n=47,33,32,32,29,28,32,32,34,33 | -1.27 | — |
| Week 16, n=47,33,32,32,29,28,32,32,34,33 | -1.22 | — |
Secondary/protocol endpoint
Change From Baseline in Fasting Fructosamine at Weeks 5, 8, 12, and 16
Time frame:Baseline and Weeks 5, 8, 12, and 16
change from baseline, improvement
Posted result
| Group | Value (mean), Micromoles per liter (µmol/L) | 95% CI |
|---|---|---|
| PlaceboWeek 5, n=48,34,32,33,28,29,32,34,35,29 | -8.3 | — |
| Week 8, n=50,34,33,34,28,29,32,34,35,31 | -10.1 | — |
| Week 12, n=50,34,33,34,28,29,32,34,35,33 | -11.2 | — |
| Week 16, n=50,34,33,34,28,29,32,34,35,33 | -3.2 | — |
| Exenatide BIDWeek 5, n=48,34,32,33,28,29,32,34,35,29 | -24.7 | — |
| Week 8, n=50,34,33,34,28,29,32,34,35,31 | -30.6 | — |
| Week 12, n=50,34,33,34,28,29,32,34,35,33 | -30.1 | — |
| Week 16, n=50,34,33,34,28,29,32,34,35,33 | -24.6 | — |
| Albiglutide 4 mg WeeklyWeek 5, n=48,34,32,33,28,29,32,34,35,29 | -11.9 | — |
| Week 8, n=50,34,33,34,28,29,32,34,35,31 | -13.1 | — |
| Week 12, n=50,34,33,34,28,29,32,34,35,33 | -12.5 | — |
| Week 16, n=50,34,33,34,28,29,32,34,35,33 | -7.8 | — |
| Albiglutide 15 mg WeeklyWeek 5, n=48,34,32,33,28,29,32,34,35,29 | -23.8 | — |
| Week 8, n=50,34,33,34,28,29,32,34,35,31 | -25.7 | — |
| Week 12, n=50,34,33,34,28,29,32,34,35,33 | -26.7 | — |
| Week 16, n=50,34,33,34,28,29,32,34,35,33 | -18.2 | — |
| Albiglutide 30 mg WeeklyWeek 5, n=48,34,32,33,28,29,32,34,35,29 | -30.7 | — |
| Week 8, n=50,34,33,34,28,29,32,34,35,31 | -35.5 | — |
| Week 12, n=50,34,33,34,28,29,32,34,35,33 | -31.8 | — |
| Week 16, n=50,34,33,34,28,29,32,34,35,33 | -30.8 | — |
| Albiglutide 15 mg Bi-weeklyWeek 5, n=48,34,32,33,28,29,32,34,35,29 | -21.3 | — |
| Week 8, n=50,34,33,34,28,29,32,34,35,31 | -28.9 | — |
| Week 12, n=50,34,33,34,28,29,32,34,35,33 | -25.2 | — |
| Week 16, n=50,34,33,34,28,29,32,34,35,33 | -23.0 | — |
| Albiglutide 30 mg Bi-weeklyWeek 5, n=48,34,32,33,28,29,32,34,35,29 | -34.4 | — |
| Week 8, n=50,34,33,34,28,29,32,34,35,31 | -40.9 | — |
| Week 12, n=50,34,33,34,28,29,32,34,35,33 | -40.2 | — |
| Week 16, n=50,34,33,34,28,29,32,34,35,33 | -38.1 | — |
| Albiglutide 50 mg Bi-weeklyWeek 5, n=48,34,32,33,28,29,32,34,35,29 | -30.1 | — |
| Week 8, n=50,34,33,34,28,29,32,34,35,31 | -32.7 | — |
| Week 12, n=50,34,33,34,28,29,32,34,35,33 | -32.7 | — |
| Week 16, n=50,34,33,34,28,29,32,34,35,33 | -29.4 | — |
| Albiglutide 50 mg Every 4 WeeksWeek 5, n=48,34,32,33,28,29,32,34,35,29 | -29.2 | — |
| Week 8, n=50,34,33,34,28,29,32,34,35,31 | -24.9 | — |
| Week 12, n=50,34,33,34,28,29,32,34,35,33 | -26.4 | — |
| Week 16, n=50,34,33,34,28,29,32,34,35,33 | -26.5 | — |
| Albiglutide 100 mg Every 4 WeeksWeek 5, n=48,34,32,33,28,29,32,34,35,29 | -32.5 | — |
| Week 8, n=50,34,33,34,28,29,32,34,35,31 | -29.5 | — |
| Week 12, n=50,34,33,34,28,29,32,34,35,33 | -31.1 | — |
| Week 16, n=50,34,33,34,28,29,32,34,35,33 | -24.9 | — |
Secondary/protocol endpoint
Change From Baseline in Fasting C-peptide at Weeks 5, 8, 12, and 16
Time frame:Baseline and Weeks 5, 8, 12, and 16
change from baseline, improvement
Posted result
| Group | Value (mean), Nanomoles per liter (nmol/L) | 95% CI |
|---|---|---|
| PlaceboWeek 5, n=48,33,32,33,27,28,32,33,35,30 | 0.004 | — |
| Week 8, n=50,34,33,34,28,29,32,33,35,31 | -0.019 | — |
| Week 12, n=50,34,33,34,28,29,32,33,35,33 | -0.092 | — |
| Week 16, n=50,34,33,34,28,29,32,33,35,33 | -0.091 | — |
| Exenatide BIDWeek 5, n=48,33,32,33,27,28,32,33,35,30 | 0.274 | — |
| Week 8, n=50,34,33,34,28,29,32,33,35,31 | 0.104 | — |
| Week 12, n=50,34,33,34,28,29,32,33,35,33 | 0.174 | — |
| Week 16, n=50,34,33,34,28,29,32,33,35,33 | 0.216 | — |
| Albiglutide 4 mg WeeklyWeek 5, n=48,33,32,33,27,28,32,33,35,30 | -0.020 | — |
| Week 8, n=50,34,33,34,28,29,32,33,35,31 | -0.073 | — |
| Week 12, n=50,34,33,34,28,29,32,33,35,33 | -0.044 | — |
| Week 16, n=50,34,33,34,28,29,32,33,35,33 | -0.051 | — |
| Albiglutide 15 mg WeeklyWeek 5, n=48,33,32,33,27,28,32,33,35,30 | -0.034 | — |
| Week 8, n=50,34,33,34,28,29,32,33,35,31 | -0.026 | — |
| Week 12, n=50,34,33,34,28,29,32,33,35,33 | -0.046 | — |
| Week 16, n=50,34,33,34,28,29,32,33,35,33 | -0.075 | — |
| Albiglutide 30 mg WeeklyWeek 5, n=48,33,32,33,27,28,32,33,35,30 | 0.089 | — |
| Week 8, n=50,34,33,34,28,29,32,33,35,31 | 0.095 | — |
| Week 12, n=50,34,33,34,28,29,32,33,35,33 | 0.023 | — |
| Week 16, n=50,34,33,34,28,29,32,33,35,33 | 0.171 | — |
| Albiglutide 15 mg Bi-weeklyWeek 5, n=48,33,32,33,27,28,32,33,35,30 | 0.015 | — |
| Week 8, n=50,34,33,34,28,29,32,33,35,31 | -0.038 | — |
| Week 12, n=50,34,33,34,28,29,32,33,35,33 | -0.098 | — |
| Week 16, n=50,34,33,34,28,29,32,33,35,33 | -0.059 | — |
| Albiglutide 30 mg Bi-weeklyWeek 5, n=48,33,32,33,27,28,32,33,35,30 | -0.128 | — |
| Week 8, n=50,34,33,34,28,29,32,33,35,31 | -0.015 | — |
| Week 12, n=50,34,33,34,28,29,32,33,35,33 | -0.153 | — |
| Week 16, n=50,34,33,34,28,29,32,33,35,33 | -0.137 | — |
| Albiglutide 50 mg Bi-weeklyWeek 5, n=48,33,32,33,27,28,32,33,35,30 | 0.004 | — |
| Week 8, n=50,34,33,34,28,29,32,33,35,31 | -0.062 | — |
| Week 12, n=50,34,33,34,28,29,32,33,35,33 | -0.076 | — |
| Week 16, n=50,34,33,34,28,29,32,33,35,33 | -0.066 | — |
| Albiglutide 50 mg Every 4 WeeksWeek 5, n=48,33,32,33,27,28,32,33,35,30 | 0.072 | — |
| Week 8, n=50,34,33,34,28,29,32,33,35,31 | 0.031 | — |
| Week 12, n=50,34,33,34,28,29,32,33,35,33 | 0.155 | — |
| Week 16, n=50,34,33,34,28,29,32,33,35,33 | 0.076 | — |
| Albiglutide 100 mg Every 4 WeeksWeek 5, n=48,33,32,33,27,28,32,33,35,30 | 0.230 | — |
| Week 8, n=50,34,33,34,28,29,32,33,35,31 | 0.007 | — |
| Week 12, n=50,34,33,34,28,29,32,33,35,33 | 0.062 | — |
| Week 16, n=50,34,33,34,28,29,32,33,35,33 | -0.005 | — |
Secondary/protocol endpoint
Change From Baseline in Fasting Glucagon at Weeks 5, 8, 12, and 16
Time frame:Baseline and Weeks 5, 8, 12, and 16
fasting glucagon
change from baseline, improvement
Posted result
| Group | Value (mean), Nanograms per liter (ng/L) | 95% CI |
|---|---|---|
| PlaceboWeek 5, n=48,33,33,33,27,28,32,34,35,30 | 3.8 | — |
| Week 8, n=50,34,34,34,28,29,32,34,35,31 | 6.9 | — |
| Week 12, n=50,34,34,34,28,29,32,34,35,33 | 0.1 | — |
| Week 16, n=50,34,34,34,28,29,32,34,35,33 | -2.1 | — |
| Exenatide BIDWeek 5, n=48,33,33,33,27,28,32,34,35,30 | -3.9 | — |
| Week 8, n=50,34,34,34,28,29,32,34,35,31 | -14.8 | — |
| Week 12, n=50,34,34,34,28,29,32,34,35,33 | -5.5 | — |
| Week 16, n=50,34,34,34,28,29,32,34,35,33 | -4.5 | — |
| Albiglutide 4 mg WeeklyWeek 5, n=48,33,33,33,27,28,32,34,35,30 | -3.2 | — |
| Week 8, n=50,34,34,34,28,29,32,34,35,31 | -5.6 | — |
| Week 12, n=50,34,34,34,28,29,32,34,35,33 | -8.6 | — |
| Week 16, n=50,34,34,34,28,29,32,34,35,33 | -3.9 | — |
| Albiglutide 15 mg WeeklyWeek 5, n=48,33,33,33,27,28,32,34,35,30 | -13.9 | — |
| Week 8, n=50,34,34,34,28,29,32,34,35,31 | -15.6 | — |
| Week 12, n=50,34,34,34,28,29,32,34,35,33 | -20.1 | — |
| Week 16, n=50,34,34,34,28,29,32,34,35,33 | -20.5 | — |
| Albiglutide 30 mg WeeklyWeek 5, n=48,33,33,33,27,28,32,34,35,30 | -3.6 | — |
| Week 8, n=50,34,34,34,28,29,32,34,35,31 | -2.4 | — |
| Week 12, n=50,34,34,34,28,29,32,34,35,33 | -4.5 | — |
| Week 16, n=50,34,34,34,28,29,32,34,35,33 | -2.6 | — |
| Albiglutide 15 mg Bi-weeklyWeek 5, n=48,33,33,33,27,28,32,34,35,30 | -6.0 | — |
| Week 8, n=50,34,34,34,28,29,32,34,35,31 | -12.4 | — |
| Week 12, n=50,34,34,34,28,29,32,34,35,33 | -11.1 | — |
| Week 16, n=50,34,34,34,28,29,32,34,35,33 | -7.1 | — |
| Albiglutide 30 mg Bi-weeklyWeek 5, n=48,33,33,33,27,28,32,34,35,30 | -7.6 | — |
| Week 8, n=50,34,34,34,28,29,32,34,35,31 | -3.1 | — |
| Week 12, n=50,34,34,34,28,29,32,34,35,33 | 0.2 | — |
| Week 16, n=50,34,34,34,28,29,32,34,35,33 | -5.0 | — |
| Albiglutide 50 mg Bi-weeklyWeek 5, n=48,33,33,33,27,28,32,34,35,30 | -11.6 | — |
| Week 8, n=50,34,34,34,28,29,32,34,35,31 | -10.7 | — |
| Week 12, n=50,34,34,34,28,29,32,34,35,33 | -3.3 | — |
| Week 16, n=50,34,34,34,28,29,32,34,35,33 | -10.9 | — |
| Albiglutide 50 mg Every 4 WeeksWeek 5, n=48,33,33,33,27,28,32,34,35,30 | -9.3 | — |
| Week 8, n=50,34,34,34,28,29,32,34,35,31 | -0.3 | — |
| Week 12, n=50,34,34,34,28,29,32,34,35,33 | -3.7 | — |
| Week 16, n=50,34,34,34,28,29,32,34,35,33 | -11.5 | — |
| Albiglutide 100 mg Every 4 WeeksWeek 5, n=48,33,33,33,27,28,32,34,35,30 | 1.9 | — |
| Week 8, n=50,34,34,34,28,29,32,34,35,31 | 0.5 | — |
| Week 12, n=50,34,34,34,28,29,32,34,35,33 | -2.1 | — |
| Week 16, n=50,34,34,34,28,29,32,34,35,33 | -4.7 | — |
Secondary/protocol endpoint
Change From Baseline in Fasting Insulin at Weeks 5, 8, 12, and 16
Time frame:Baseline and Weeks 5, 8, 12, and 16
change from baseline, improvement
Posted result
| Group | Value (mean), Picomoles per liter (pmol/L) | 95% CI |
|---|---|---|
| PlaceboWeek 5, n=47,31,32,33,27,28,31,30,33,30 | 5.1 | — |
| Week 8, n=49,32,33,34,28,29,32,31,33,31 | 9.2 | — |
| Week 12, n=49,32,33,34,28,29,32,31,33,33 | 8.8 | — |
| Week 16, n=49,32,33,34,28,29,32,31,33,33 | -5.8 | — |
| Exenatide BIDWeek 5, n=47,31,32,33,27,28,31,30,33,30 | 29.6 | — |
| Week 8, n=49,32,33,34,28,29,32,31,33,31 | 5.4 | — |
| Week 12, n=49,32,33,34,28,29,32,31,33,33 | 18.0 | — |
| Week 16, n=49,32,33,34,28,29,32,31,33,33 | 17.4 | — |
| Albiglutide 4 mg WeeklyWeek 5, n=47,31,32,33,27,28,31,30,33,30 | -12.4 | — |
| Week 8, n=49,32,33,34,28,29,32,31,33,31 | -16.5 | — |
| Week 12, n=49,32,33,34,28,29,32,31,33,33 | -12.4 | — |
| Week 16, n=49,32,33,34,28,29,32,31,33,33 | 2.9 | — |
| Albiglutide 15 mg WeeklyWeek 5, n=47,31,32,33,27,28,31,30,33,30 | -16.4 | — |
| Week 8, n=49,32,33,34,28,29,32,31,33,31 | -8.5 | — |
| Week 12, n=49,32,33,34,28,29,32,31,33,33 | -7.9 | — |
| Week 16, n=49,32,33,34,28,29,32,31,33,33 | -19.9 | — |
| Albiglutide 30 mg WeeklyWeek 5, n=47,31,32,33,27,28,31,30,33,30 | 0.4 | — |
| Week 8, n=49,32,33,34,28,29,32,31,33,31 | 2.4 | — |
| Week 12, n=49,32,33,34,28,29,32,31,33,33 | -1.1 | — |
| Week 16, n=49,32,33,34,28,29,32,31,33,33 | 25.1 | — |
| Albiglutide 15 mg Bi-weeklyWeek 5, n=47,31,32,33,27,28,31,30,33,30 | 28.5 | — |
| Week 8, n=49,32,33,34,28,29,32,31,33,31 | 18.6 | — |
| Week 12, n=49,32,33,34,28,29,32,31,33,33 | 17.8 | — |
| Week 16, n=49,32,33,34,28,29,32,31,33,33 | 21.9 | — |
| Albiglutide 30 mg Bi-weeklyWeek 5, n=47,31,32,33,27,28,31,30,33,30 | -38.3 | — |
| Week 8, n=49,32,33,34,28,29,32,31,33,31 | -14.4 | — |
| Week 12, n=49,32,33,34,28,29,32,31,33,33 | -26.1 | — |
| Week 16, n=49,32,33,34,28,29,32,31,33,33 | -24.0 | — |
| Albiglutide 50 mg Bi-weeklyWeek 5, n=47,31,32,33,27,28,31,30,33,30 | -8.4 | — |
| Week 8, n=49,32,33,34,28,29,32,31,33,31 | -16.8 | — |
| Week 12, n=49,32,33,34,28,29,32,31,33,33 | 0.2 | — |
| Week 16, n=49,32,33,34,28,29,32,31,33,33 | -17.4 | — |
| Albiglutide 50 mg Every 4 WeeksWeek 5, n=47,31,32,33,27,28,31,30,33,30 | 11.1 | — |
| Week 8, n=49,32,33,34,28,29,32,31,33,31 | 12.9 | — |
| Week 12, n=49,32,33,34,28,29,32,31,33,33 | 38.0 | — |
| Week 16, n=49,32,33,34,28,29,32,31,33,33 | 12.9 | — |
| Albiglutide 100 mg Every 4 WeeksWeek 5, n=47,31,32,33,27,28,31,30,33,30 | 36.2 | — |
| Week 8, n=49,32,33,34,28,29,32,31,33,31 | 6.6 | — |
| Week 12, n=49,32,33,34,28,29,32,31,33,33 | 11.6 | — |
| Week 16, n=49,32,33,34,28,29,32,31,33,33 | 18.4 | — |
Cardiometabolic biomarkers
1 endpointSecondary/protocol endpoint
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
Time frame:Baseline and Weeks 5, 8, 12, and 16
change from baseline, improvement
componentsTriglycerides, change, Free fatty acids, change, Total cholesterol, change, LDL-C, change, HDL-C, change
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| PlaceboTG, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.225 | — |
| TG, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.222 | — |
| TG, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.329 | — |
| TG, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.377 | — |
| FFA, Week 5, n=48,33,32,33,27,28,32,34,35,29 | 0.029 | — |
| FFA, Week 8, n=50,34,33,34,28,29,32,34,35,31 | 0.034 | — |
| FFA, Week 12, n=50,34,33,34,28,29,32,34,35,33 | 0.075 | — |
| FFA, Week 16, n=50,34,33,34,28,29,32,34,35,33 | 0.078 | — |
| Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.023 | — |
| Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.050 | — |
| Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33 | 0.045 | — |
| Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33 | 0.095 | — |
| LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29 | 0.066 | — |
| LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,30 | 0.066 | — |
| LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,32 | 0.138 | — |
| LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,32 | 0.190 | — |
| HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.020 | — |
| HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.005 | — |
| HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.011 | — |
| HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.002 | — |
| Exenatide BIDTG, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.068 | — |
| TG, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.238 | — |
| TG, Week 12, n=50,34,34,34,28,30,32,34,35,33 | 0.094 | — |
| TG, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.149 | — |
| FFA, Week 5, n=48,33,32,33,27,28,32,34,35,29 | -0.038 | — |
| FFA, Week 8, n=50,34,33,34,28,29,32,34,35,31 | -0.045 | — |
| FFA, Week 12, n=50,34,33,34,28,29,32,34,35,33 | -0.007 | — |
| FFA, Week 16, n=50,34,33,34,28,29,32,34,35,33 | -0.031 | — |
| Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.239 | — |
| Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.182 | — |
| Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33 | 0.054 | — |
| Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.031 | — |
| LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29 | -0.153 | — |
| LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,30 | -0.014 | — |
| LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,32 | 0.105 | — |
| LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,32 | 0.096 | — |
| HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.047 | — |
| HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.058 | — |
| HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.003 | — |
| HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.025 | — |
| Albiglutide 4 mg WeeklyTG, Week 5, n=45,31,34,31,27,29,31,34,35,30 | 0.303 | — |
| TG, Week 8, n=50,33,34,34,27,30,32,34,35,31 | 0.178 | — |
| TG, Week 12, n=50,34,34,34,28,30,32,34,35,33 | 0.221 | — |
| TG, Week 16, n=50,34,34,34,28,30,32,34,35,33 | 0.122 | — |
| FFA, Week 5, n=48,33,32,33,27,28,32,34,35,29 | -0.032 | — |
| FFA, Week 8, n=50,34,33,34,28,29,32,34,35,31 | 0.033 | — |
| FFA, Week 12, n=50,34,33,34,28,29,32,34,35,33 | 0.022 | — |
| FFA, Week 16, n=50,34,33,34,28,29,32,34,35,33 | 0.020 | — |
| Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.153 | — |
| Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.060 | — |
| Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.025 | — |
| Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.032 | — |
| LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29 | -0.294 | — |
| LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,30 | -0.132 | — |
| LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,32 | -0.096 | — |
| LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,32 | -0.109 | — |
| HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30 | 0.001 | — |
| HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31 | 0.006 | — |
| HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33 | 0.004 | — |
| HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.007 | — |
| Albiglutide 15 mg WeeklyTG, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.376 | — |
| TG, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.408 | — |
| TG, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.341 | — |
| TG, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.296 | — |
| FFA, Week 5, n=48,33,32,33,27,28,32,34,35,29 | -0.008 | — |
| FFA, Week 8, n=50,34,33,34,28,29,32,34,35,31 | -0.048 | — |
| FFA, Week 12, n=50,34,33,34,28,29,32,34,35,33 | -0.013 | — |
| FFA, Week 16, n=50,34,33,34,28,29,32,34,35,33 | 0.016 | — |
| Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.139 | — |
| Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.162 | — |
| Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.140 | — |
| Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.037 | — |
| LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29 | -0.155 | — |
| LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,30 | -0.157 | — |
| LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,32 | -0.152 | — |
| LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,32 | -0.045 | — |
| HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.010 | — |
| HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31 | 0.019 | — |
| HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.019 | — |
| HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.010 | — |
| Albiglutide 30 mg WeeklyTG, Week 5, n=45,31,34,31,27,29,31,34,35,30 | 0.112 | — |
| TG, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.009 | — |
| TG, Week 12, n=50,34,34,34,28,30,32,34,35,33 | 0.106 | — |
| TG, Week 16, n=50,34,34,34,28,30,32,34,35,33 | 0.099 | — |
| FFA, Week 5, n=48,33,32,33,27,28,32,34,35,29 | 0.014 | — |
| FFA, Week 8, n=50,34,33,34,28,29,32,34,35,31 | 0.046 | — |
| FFA, Week 12, n=50,34,33,34,28,29,32,34,35,33 | 0.043 | — |
| FFA, Week 16, n=50,34,33,34,28,29,32,34,35,33 | 0.050 | — |
| Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.113 | — |
| Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31 | 0.002 | — |
| Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.020 | — |
| Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33 | 0.009 | — |
| LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29 | -0.068 | — |
| LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,30 | 0.089 | — |
| LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,32 | 0.004 | — |
| LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,32 | 0.003 | — |
| HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.063 | — |
| HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.061 | — |
| HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.061 | — |
| HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.046 | — |
| Albiglutide 15 mg Bi-weeklyTG, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.266 | — |
| TG, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.219 | — |
| TG, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.380 | — |
| TG, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.258 | — |
| FFA, Week 5, n=48,33,32,33,27,28,32,34,35,29 | 0.025 | — |
| FFA, Week 8, n=50,34,33,34,28,29,32,34,35,31 | 0.017 | — |
| FFA, Week 12, n=50,34,33,34,28,29,32,34,35,33 | 0.010 | — |
| FFA, Week 16, n=50,34,33,34,28,29,32,34,35,33 | 0.034 | — |
| Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.372 | — |
| Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.172 | — |
| Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.190 | — |
| Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.225 | — |
| LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29 | -0.285 | — |
| LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,30 | -0.160 | — |
| LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,32 | -0.034 | — |
| LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,32 | -0.123 | — |
| HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.038 | — |
| HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.018 | — |
| HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.018 | — |
| HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.015 | — |
| Albiglutide 30 mg Bi-weeklyTG, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.147 | — |
| TG, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.150 | — |
| TG, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.269 | — |
| TG, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.331 | — |
| FFA, Week 5, n=48,33,32,33,27,28,32,34,35,29 | -0.028 | — |
| FFA, Week 8, n=50,34,33,34,28,29,32,34,35,31 | -0.027 | — |
| FFA, Week 12, n=50,34,33,34,28,29,32,34,35,33 | -0.051 | — |
| FFA, Week 16, n=50,34,33,34,28,29,32,34,35,33 | -0.005 | — |
| Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.140 | — |
| Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.094 | — |
| Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.092 | — |
| Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.178 | — |
| LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29 | -0.082 | — |
| LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,30 | -0.052 | — |
| LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,32 | -0.004 | — |
| LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,32 | -0.062 | — |
| HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.045 | — |
| HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.030 | — |
| HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.041 | — |
| HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.031 | — |
| Albiglutide 50 mg Bi-weeklyTG, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -1.423 | — |
| TG, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -1.494 | — |
| TG, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -1.539 | — |
| TG, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -1.469 | — |
| FFA, Week 5, n=48,33,32,33,27,28,32,34,35,29 | -0.012 | — |
| FFA, Week 8, n=50,34,33,34,28,29,32,34,35,31 | -0.004 | — |
| FFA, Week 12, n=50,34,33,34,28,29,32,34,35,33 | 0.011 | — |
| FFA, Week 16, n=50,34,33,34,28,29,32,34,35,33 | 0.025 | — |
| Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.451 | — |
| Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.418 | — |
| Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.338 | — |
| Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.447 | — |
| LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29 | 0.026 | — |
| LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,30 | 0.053 | — |
| LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,32 | 0.156 | — |
| LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,32 | 0.059 | — |
| HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.076 | — |
| HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.050 | — |
| HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.029 | — |
| HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.065 | — |
| Albiglutide 50 mg Every 4 WeeksTG, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.725 | — |
| TG, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.175 | — |
| TG, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.362 | — |
| TG, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.426 | — |
| FFA, Week 5, n=48,33,32,33,27,28,32,34,35,29 | -0.001 | — |
| FFA, Week 8, n=50,34,33,34,28,29,32,34,35,31 | 0.055 | — |
| FFA, Week 12, n=50,34,33,34,28,29,32,34,35,33 | -0.030 | — |
| FFA, Week 16, n=50,34,33,34,28,29,32,34,35,33 | 0.012 | — |
| Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.407 | — |
| Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.183 | — |
| Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.134 | — |
| Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.217 | — |
| LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29 | -0.106 | — |
| LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,30 | -0.087 | — |
| LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,32 | -0.061 | — |
| LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,32 | -0.088 | — |
| HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.047 | — |
| HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.054 | — |
| HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.033 | — |
| HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.033 | — |
| Albiglutide 100 mg Every 4 WeeksTG, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.184 | — |
| TG, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.028 | — |
| TG, Week 12, n=50,34,34,34,28,30,32,34,35,33 | 0.070 | — |
| TG, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.114 | — |
| FFA, Week 5, n=48,33,32,33,27,28,32,34,35,29 | 0.006 | — |
| FFA, Week 8, n=50,34,33,34,28,29,32,34,35,31 | 0.175 | — |
| FFA, Week 12, n=50,34,33,34,28,29,32,34,35,33 | 0.123 | — |
| FFA, Week 16, n=50,34,33,34,28,29,32,34,35,33 | 0.094 | — |
| Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.245 | — |
| Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31 | 0.060 | — |
| Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33 | 0.015 | — |
| Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33 | 0.018 | — |
| LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29 | -0.091 | — |
| LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,30 | 0.054 | — |
| LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,32 | 0.010 | — |
| LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,32 | 0.054 | — |
| HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30 | -0.053 | — |
| HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31 | -0.016 | — |
| HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33 | -0.045 | — |
| HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33 | -0.048 | — |
Patient-reported / QoL
2 endpointsSecondary/protocol endpoint
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
Time frame:Baseline and Week 16
change from baseline, improvement
Posted result
| Group | Value (mean), Score on a scale | 95% CI |
|---|---|---|
| PlaceboFLIEQ1 | -0.1 | — |
| FLIEQ2 | 0.2 | — |
| FLIEQ3 | 15.6 | — |
| FLIEQ4 | 0.4 | — |
| FLIEQ5 | -0.3 | — |
| FLIEQ6 | 11.2 | — |
| FLIEQ7 | 0.4 | — |
| FLIEQ8 | -0.6 | — |
| FLIEQ9 | -0.1 | — |
| FLIEQ10 | -0.3 | — |
| FLIEQ11 | 15.3 | — |
| FLIEQ12 | 0.1 | — |
| FLIEQ13 | 0.1 | — |
| FLIEQ14 | -0.3 | — |
| FLIEQ15 | 15.5 | — |
| FLIEQ16 | -0.4 | — |
| FLIEQ17 | 0.1 | — |
| FLIEQ18 | 18.1 | — |
| Exenatide BIDFLIEQ1 | -4.4 | — |
| FLIEQ2 | -3.5 | — |
| FLIEQ3 | 7.8 | — |
| FLIEQ4 | -3.5 | — |
| FLIEQ5 | -4.0 | — |
| FLIEQ6 | 3.6 | — |
| FLIEQ7 | -3.1 | — |
| FLIEQ8 | -3.5 | — |
| FLIEQ9 | -3.4 | — |
| FLIEQ10 | -4.9 | — |
| FLIEQ11 | 3.3 | — |
| FLIEQ12 | -3.1 | — |
| FLIEQ13 | -4.0 | — |
| FLIEQ14 | -4.1 | — |
| FLIEQ15 | 7.0 | — |
| FLIEQ16 | -3.8 | — |
| FLIEQ17 | -4.1 | — |
| FLIEQ18 | 6.9 | — |
| Albiglutide 4 mg WeeklyFLIEQ1 | 5.7 | — |
| FLIEQ2 | 5.5 | — |
| FLIEQ3 | 10.3 | — |
| FLIEQ4 | 6.4 | — |
| FLIEQ5 | 6.4 | — |
| FLIEQ6 | 9.4 | — |
| FLIEQ7 | 5.7 | — |
| FLIEQ8 | 5.7 | — |
| FLIEQ9 | 5.3 | — |
| FLIEQ10 | 5.8 | — |
| FLIEQ11 | 13.8 | — |
| FLIEQ12 | 6.4 | — |
| FLIEQ13 | 6.3 | — |
| FLIEQ14 | 6.4 | — |
| FLIEQ15 | 14.2 | — |
| FLIEQ16 | 6.3 | — |
| FLIEQ17 | 6.3 | — |
| FLIEQ18 | 14.2 | — |
| Albiglutide 15 mg WeeklyFLIEQ1 | 1.0 | — |
| FLIEQ2 | 2.6 | — |
| FLIEQ3 | -4.0 | — |
| FLIEQ4 | -2.8 | — |
| FLIEQ5 | -1.8 | — |
| FLIEQ6 | -0.5 | — |
| FLIEQ7 | 1.5 | — |
| FLIEQ8 | -1.0 | — |
| FLIEQ9 | -0.5 | — |
| FLIEQ10 | -1.6 | — |
| FLIEQ11 | -0.5 | — |
| FLIEQ12 | -0.8 | — |
| FLIEQ13 | -2.2 | — |
| FLIEQ14 | -1.4 | — |
| FLIEQ15 | -4.9 | — |
| FLIEQ16 | -1.4 | — |
| FLIEQ17 | -1.2 | — |
| FLIEQ18 | -3.2 | — |
| Albiglutide 30 mg WeeklyFLIEQ1 | 4.6 | — |
| FLIEQ2 | 3.0 | — |
| FLIEQ3 | 18.6 | — |
| FLIEQ4 | 1.5 | — |
| FLIEQ5 | 2.9 | — |
| FLIEQ6 | 20.0 | — |
| FLIEQ7 | 0.2 | — |
| FLIEQ8 | 2.6 | — |
| FLIEQ9 | 2.3 | — |
| FLIEQ10 | -0.1 | — |
| FLIEQ11 | 21.9 | — |
| FLIEQ12 | 1.8 | — |
| FLIEQ13 | 1.0 | — |
| FLIEQ14 | 1.8 | — |
| FLIEQ15 | 19.7 | — |
| FLIEQ16 | -0.5 | — |
| FLIEQ17 | -1.2 | — |
| FLIEQ18 | 14.9 | — |
| Albiglutide 15 mg Bi-weeklyFLIEQ1 | 8.6 | — |
| FLIEQ2 | 5.9 | — |
| FLIEQ3 | 10.3 | — |
| FLIEQ4 | 5.6 | — |
| FLIEQ5 | 0.2 | — |
| FLIEQ6 | 10.2 | — |
| FLIEQ7 | 5.7 | — |
| FLIEQ8 | 10.1 | — |
| FLIEQ9 | 5.6 | — |
| FLIEQ10 | 4.5 | — |
| FLIEQ11 | 7.9 | — |
| FLIEQ12 | 5.3 | — |
| FLIEQ13 | 9.8 | — |
| FLIEQ14 | 5.3 | — |
| FLIEQ15 | 5.6 | — |
| FLIEQ16 | 8.2 | — |
| FLIEQ17 | 4.5 | — |
| FLIEQ18 | 10.1 | — |
| Albiglutide 30 mg Bi-weeklyFLIEQ1 | -1.0 | — |
| FLIEQ2 | -0.8 | — |
| FLIEQ3 | 3.9 | — |
| FLIEQ4 | -1.6 | — |
| FLIEQ5 | -1.3 | — |
| FLIEQ6 | 4.2 | — |
| FLIEQ7 | -1.0 | — |
| FLIEQ8 | -0.7 | — |
| FLIEQ9 | -0.7 | — |
| FLIEQ10 | -0.3 | — |
| FLIEQ11 | 3.6 | — |
| FLIEQ12 | -0.2 | — |
| FLIEQ13 | -0.3 | — |
| FLIEQ14 | -0.1 | — |
| FLIEQ15 | 3.5 | — |
| FLIEQ16 | -0.1 | — |
| FLIEQ17 | -0.2 | — |
| FLIEQ18 | 7.1 | — |
| Albiglutide 50 mg Bi-weeklyFLIEQ1 | 8.2 | — |
| FLIEQ2 | 4.7 | — |
| FLIEQ3 | 18.2 | — |
| FLIEQ4 | 5.9 | — |
| FLIEQ5 | 4.5 | — |
| FLIEQ6 | 18.0 | — |
| FLIEQ7 | 4.9 | — |
| FLIEQ8 | 6.2 | — |
| FLIEQ9 | 4.0 | — |
| FLIEQ10 | 4.3 | — |
| FLIEQ11 | 18.3 | — |
| FLIEQ12 | 4.4 | — |
| FLIEQ13 | 4.3 | — |
| FLIEQ14 | 4.3 | — |
| FLIEQ15 | 18.4 | — |
| FLIEQ16 | 4.5 | — |
| FLIEQ17 | 4.3 | — |
| FLIEQ18 | 18.5 | — |
| Albiglutide 50 mg Every 4 WeeksFLIEQ1 | -0.3 | — |
| FLIEQ2 | -0.6 | — |
| FLIEQ3 | 4.5 | — |
| FLIEQ4 | -1.9 | — |
| FLIEQ5 | 1.5 | — |
| FLIEQ6 | 5.6 | — |
| FLIEQ7 | -0.1 | — |
| FLIEQ8 | -0.4 | — |
| FLIEQ9 | -0.1 | — |
| FLIEQ10 | 0.2 | — |
| FLIEQ11 | 7.2 | — |
| FLIEQ12 | -0.4 | — |
| FLIEQ13 | 0.0 | — |
| FLIEQ14 | -0.1 | — |
| FLIEQ15 | 1.5 | — |
| FLIEQ16 | 0.9 | — |
| FLIEQ17 | -1.1 | — |
| FLIEQ18 | 5.7 | — |
| Albiglutide 100 mg Every 4 WeeksFLIEQ1 | -2.8 | — |
| FLIEQ2 | -0.2 | — |
| FLIEQ3 | 7.3 | — |
| FLIEQ4 | -1.8 | — |
| FLIEQ5 | -1.4 | — |
| FLIEQ6 | 3.9 | — |
| FLIEQ7 | -1.9 | — |
| FLIEQ8 | -2.3 | — |
| FLIEQ9 | -3.2 | — |
| FLIEQ10 | -2.0 | — |
| FLIEQ11 | 4.0 | — |
| FLIEQ12 | -0.8 | — |
| FLIEQ13 | -2.1 | — |
| FLIEQ14 | -2.1 | — |
| FLIEQ15 | 4.0 | — |
| FLIEQ16 | -1.5 | — |
| FLIEQ17 | -0.6 | — |
| FLIEQ18 | 6.9 | — |
Secondary/protocol endpoint
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Time frame:Week 16
threshold achievement, improvement
Posted result
| Group | Value (number), Participants | 95% CI |
|---|---|---|
| PlaceboQ1: Always | 1 | — |
| Q1: Often | 5 | — |
| Q1: Sometimes | 28 | — |
| Q1: Rarely | 4 | — |
| Q1: Never | 1 | — |
| Q2: Always | 1 | — |
| Q2: Often | 4 | — |
| Q2: Sometimes | 28 | — |
| Q2: Rarely | 5 | — |
| Q2: Never | 1 | — |
| Q3: Always | 3 | — |
| Q3: Often | 7 | — |
| Q3: Sometimes | 26 | — |
| Q3: Rarely | 3 | — |
| Q3: Never | 0 | — |
| Q4: Yes, definitely | 4 | — |
| Q4: Yes, probably | 15 | — |
| Q4: I don't know | 10 | — |
| Q4: Probably not | 7 | — |
| Q4: Definitely not | 3 | — |
| Q5: Always | 1 | — |
| Q5: Often | 2 | — |
| Q5: Sometimes | 19 | — |
| Q5: Rarely | 16 | — |
| Q5: Never | 1 | — |
| Q6: Much too full | 0 | — |
| Q6: Very full | 10 | — |
| Q6: Comfortably full | 26 | — |
| Q6: Slightly hungry | 3 | — |
| Q6: Very hungry | 0 | — |
| Q7: Extremely satisfied | 3 | — |
| Q7: Satisfied | 27 | — |
| Q7: Neither satisfied nor dissatisfied | 9 | — |
| Q7: Dissatisfied | 0 | — |
| Q7: Extremely dissatisfied | 0 | — |
| Exenatide BIDQ1: Always | 0 | — |
| Q1: Often | 5 | — |
| Q1: Sometimes | 17 | — |
| Q1: Rarely | 7 | — |
| Q1: Never | 1 | — |
| Q2: Always | 1 | — |
| Q2: Often | 5 | — |
| Q2: Sometimes | 19 | — |
| Q2: Rarely | 4 | — |
| Q2: Never | 1 | — |
| Q3: Always | 0 | — |
| Q3: Often | 5 | — |
| Q3: Sometimes | 20 | — |
| Q3: Rarely | 5 | — |
| Q3: Never | 0 | — |
| Q4: Yes, definitely | 1 | — |
| Q4: Yes, probably | 8 | — |
| Q4: I don't know | 5 | — |
| Q4: Probably not | 12 | — |
| Q4: Definitely not | 4 | — |
| Q5: Always | 1 | — |
| Q5: Often | 2 | — |
| Q5: Sometimes | 15 | — |
| Q5: Rarely | 8 | — |
| Q5: Never | 4 | — |
| Q6: Much too full | 0 | — |
| Q6: Very full | 2 | — |
| Q6: Comfortably full | 28 | — |
| Q6: Slightly hungry | 0 | — |
| Q6: Very hungry | 0 | — |
| Q7: Extremely satisfied | 0 | — |
| Q7: Satisfied | 27 | — |
| Q7: Neither satisfied nor dissatisfied | 3 | — |
| Q7: Dissatisfied | 0 | — |
| Q7: Extremely dissatisfied | 0 | — |
| Albiglutide 4 mg WeeklyQ1: Always | 0 | — |
| Q1: Often | 2 | — |
| Q1: Sometimes | 15 | — |
| Q1: Rarely | 3 | — |
| Q1: Never | 1 | — |
| Q2: Always | 0 | — |
| Q2: Often | 2 | — |
| Q2: Sometimes | 14 | — |
| Q2: Rarely | 5 | — |
| Q2: Never | 0 | — |
| Q3: Always | 0 | — |
| Q3: Often | 4 | — |
| Q3: Sometimes | 16 | — |
| Q3: Rarely | 1 | — |
| Q3: Never | 0 | — |
| Q4: Yes, definitely | 0 | — |
| Q4: Yes, probably | 8 | — |
| Q4: I don't know | 2 | — |
| Q4: Probably not | 10 | — |
| Q4: Definitely not | 1 | — |
| Q5: Always | 0 | — |
| Q5: Often | 2 | — |
| Q5: Sometimes | 5 | — |
| Q5: Rarely | 11 | — |
| Q5: Never | 3 | — |
| Q6: Much too full | 0 | — |
| Q6: Very full | 3 | — |
| Q6: Comfortably full | 18 | — |
| Q6: Slightly hungry | 0 | — |
| Q6: Very hungry | 0 | — |
| Q7: Extremely satisfied | 1 | — |
| Q7: Satisfied | 17 | — |
| Q7: Neither satisfied nor dissatisfied | 3 | — |
| Q7: Dissatisfied | 0 | — |
| Q7: Extremely dissatisfied | 0 | — |
| Albiglutide 15 mg WeeklyQ1: Always | 0 | — |
| Q1: Often | 7 | — |
| Q1: Sometimes | 14 | — |
| Q1: Rarely | 4 | — |
| Q1: Never | 0 | — |
| Q2: Always | 0 | — |
| Q2: Often | 7 | — |
| Q2: Sometimes | 13 | — |
| Q2: Rarely | 5 | — |
| Q2: Never | 0 | — |
| Q3: Always | 1 | — |
| Q3: Often | 4 | — |
| Q3: Sometimes | 18 | — |
| Q3: Rarely | 2 | — |
| Q3: Never | 0 | — |
| Q4: Yes, definitely | 2 | — |
| Q4: Yes, probably | 9 | — |
| Q4: I don't know | 1 | — |
| Q4: Probably not | 9 | — |
| Q4: Definitely not | 4 | — |
| Q5: Always | 0 | — |
| Q5: Often | 4 | — |
| Q5: Sometimes | 13 | — |
| Q5: Rarely | 4 | — |
| Q5: Never | 4 | — |
| Q6: Much too full | 1 | — |
| Q6: Very full | 5 | — |
| Q6: Comfortably full | 17 | — |
| Q6: Slightly hungry | 2 | — |
| Q6: Very hungry | 0 | — |
| Q7: Extremely satisfied | 1 | — |
| Q7: Satisfied | 17 | — |
| Q7: Neither satisfied nor dissatisfied | 5 | — |
| Q7: Dissatisfied | 2 | — |
| Q7: Extremely dissatisfied | 0 | — |
| Albiglutide 30 mg WeeklyQ1: Always | 0 | — |
| Q1: Often | 6 | — |
| Q1: Sometimes | 14 | — |
| Q1: Rarely | 2 | — |
| Q1: Never | 0 | — |
| Q2: Always | 0 | — |
| Q2: Often | 7 | — |
| Q2: Sometimes | 11 | — |
| Q2: Rarely | 4 | — |
| Q2: Never | 0 | — |
| Q3: Always | 1 | — |
| Q3: Often | 7 | — |
| Q3: Sometimes | 13 | — |
| Q3: Rarely | 1 | — |
| Q3: Never | 0 | — |
| Q4: Yes, definitely | 2 | — |
| Q4: Yes, probably | 9 | — |
| Q4: I don't know | 1 | — |
| Q4: Probably not | 7 | — |
| Q4: Definitely not | 3 | — |
| Q5: Always | 2 | — |
| Q5: Often | 1 | — |
| Q5: Sometimes | 14 | — |
| Q5: Rarely | 5 | — |
| Q5: Never | 0 | — |
| Q6: Much too full | 0 | — |
| Q6: Very full | 3 | — |
| Q6: Comfortably full | 18 | — |
| Q6: Slightly hungry | 1 | — |
| Q6: Very hungry | 0 | — |
| Q7: Extremely satisfied | 1 | — |
| Q7: Satisfied | 19 | — |
| Q7: Neither satisfied nor dissatisfied | 1 | — |
| Q7: Dissatisfied | 1 | — |
| Q7: Extremely dissatisfied | 0 | — |
| Albiglutide 15 mg Bi-weeklyQ1: Always | 2 | — |
| Q1: Often | 3 | — |
| Q1: Sometimes | 8 | — |
| Q1: Rarely | 6 | — |
| Q1: Never | 0 | — |
| Q2: Always | 1 | — |
| Q2: Often | 3 | — |
| Q2: Sometimes | 10 | — |
| Q2: Rarely | 4 | — |
| Q2: Never | 1 | — |
| Q3: Always | 1 | — |
| Q3: Often | 4 | — |
| Q3: Sometimes | 10 | — |
| Q3: Rarely | 4 | — |
| Q3: Never | 0 | — |
| Q4: Yes, definitely | 2 | — |
| Q4: Yes, probably | 9 | — |
| Q4: I don't know | 2 | — |
| Q4: Probably not | 4 | — |
| Q4: Definitely not | 2 | — |
| Q5: Always | 0 | — |
| Q5: Often | 1 | — |
| Q5: Sometimes | 7 | — |
| Q5: Rarely | 8 | — |
| Q5: Never | 3 | — |
| Q6: Much too full | 0 | — |
| Q6: Very full | 4 | — |
| Q6: Comfortably full | 13 | — |
| Q6: Slightly hungry | 2 | — |
| Q6: Very hungry | 0 | — |
| Q7: Extremely satisfied | 0 | — |
| Q7: Satisfied | 15 | — |
| Q7: Neither satisfied nor dissatisfied | 3 | — |
| Q7: Dissatisfied | 1 | — |
| Q7: Extremely dissatisfied | 0 | — |
| Albiglutide 30 mg Bi-weeklyQ1: Always | 2 | — |
| Q1: Often | 5 | — |
| Q1: Sometimes | 17 | — |
| Q1: Rarely | 0 | — |
| Q1: Never | 1 | — |
| Q2: Always | 3 | — |
| Q2: Often | 6 | — |
| Q2: Sometimes | 15 | — |
| Q2: Rarely | 0 | — |
| Q2: Never | 1 | — |
| Q3: Always | 4 | — |
| Q3: Often | 4 | — |
| Q3: Sometimes | 16 | — |
| Q3: Rarely | 1 | — |
| Q3: Never | 0 | — |
| Q4: Yes, definitely | 2 | — |
| Q4: Yes, probably | 12 | — |
| Q4: I don't know | 4 | — |
| Q4: Probably not | 4 | — |
| Q4: Definitely not | 3 | — |
| Q5: Always | 2 | — |
| Q5: Often | 6 | — |
| Q5: Sometimes | 15 | — |
| Q5: Rarely | 2 | — |
| Q5: Never | 0 | — |
| Q6: Much too full | 1 | — |
| Q6: Very full | 4 | — |
| Q6: Comfortably full | 20 | — |
| Q6: Slightly hungry | 0 | — |
| Q6: Very hungry | 0 | — |
| Q7: Extremely satisfied | 2 | — |
| Q7: Satisfied | 22 | — |
| Q7: Neither satisfied nor dissatisfied | 1 | — |
| Q7: Dissatisfied | 0 | — |
| Q7: Extremely dissatisfied | 0 | — |
| Albiglutide 50 mg Bi-weeklyQ1: Always | 2 | — |
| Q1: Often | 2 | — |
| Q1: Sometimes | 11 | — |
| Q1: Rarely | 4 | — |
| Q1: Never | 2 | — |
| Q2: Always | 2 | — |
| Q2: Often | 3 | — |
| Q2: Sometimes | 9 | — |
| Q2: Rarely | 4 | — |
| Q2: Never | 3 | — |
| Q3: Always | 3 | — |
| Q3: Often | 2 | — |
| Q3: Sometimes | 12 | — |
| Q3: Rarely | 2 | — |
| Q3: Never | 2 | — |
| Q4: Yes, definitely | 2 | — |
| Q4: Yes, probably | 5 | — |
| Q4: I don't know | 2 | — |
| Q4: Probably not | 5 | — |
| Q4: Definitely not | 7 | — |
| Q5: Always | 0 | — |
| Q5: Often | 3 | — |
| Q5: Sometimes | 9 | — |
| Q5: Rarely | 6 | — |
| Q5: Never | 3 | — |
| Q6: Much too full | 1 | — |
| Q6: Very full | 2 | — |
| Q6: Comfortably full | 18 | — |
| Q6: Slightly hungry | 0 | — |
| Q6: Very hungry | 0 | — |
| Q7: Extremely satisfied | 1 | — |
| Q7: Satisfied | 15 | — |
| Q7: Neither satisfied nor dissatisfied | 5 | — |
| Q7: Dissatisfied | 0 | — |
| Q7: Extremely dissatisfied | 0 | — |
| Albiglutide 50 mg Every 4 WeeksQ1: Always | 2 | — |
| Q1: Often | 6 | — |
| Q1: Sometimes | 20 | — |
| Q1: Rarely | 2 | — |
| Q1: Never | 0 | — |
| Q2: Always | 3 | — |
| Q2: Often | 6 | — |
| Q2: Sometimes | 16 | — |
| Q2: Rarely | 4 | — |
| Q2: Never | 1 | — |
| Q3: Always | 3 | — |
| Q3: Often | 6 | — |
| Q3: Sometimes | 17 | — |
| Q3: Rarely | 4 | — |
| Q3: Never | 0 | — |
| Q4: Yes, definitely | 7 | — |
| Q4: Yes, probably | 9 | — |
| Q4: I don't know | 2 | — |
| Q4: Probably not | 10 | — |
| Q4: Definitely not | 2 | — |
| Q5: Always | 0 | — |
| Q5: Often | 5 | — |
| Q5: Sometimes | 11 | — |
| Q5: Rarely | 9 | — |
| Q5: Never | 5 | — |
| Q6: Much too full | 2 | — |
| Q6: Very full | 7 | — |
| Q6: Comfortably full | 18 | — |
| Q6: Slightly hungry | 2 | — |
| Q6: Very hungry | 1 | — |
| Q7: Extremely satisfied | 2 | — |
| Q7: Satisfied | 23 | — |
| Q7: Neither satisfied nor dissatisfied | 4 | — |
| Q7: Dissatisfied | 1 | — |
| Q7: Extremely dissatisfied | 0 | — |
| Albiglutide 100 mg Every 4 WeeksQ1: Always | 1 | — |
| Q1: Often | 6 | — |
| Q1: Sometimes | 12 | — |
| Q1: Rarely | 2 | — |
| Q1: Never | 1 | — |
| Q2: Always | 2 | — |
| Q2: Often | 6 | — |
| Q2: Sometimes | 11 | — |
| Q2: Rarely | 2 | — |
| Q2: Never | 1 | — |
| Q3: Always | 0 | — |
| Q3: Often | 9 | — |
| Q3: Sometimes | 11 | — |
| Q3: Rarely | 1 | — |
| Q3: Never | 1 | — |
| Q4: Yes, definitely | 3 | — |
| Q4: Yes, probably | 12 | — |
| Q4: I don't know | 2 | — |
| Q4: Probably not | 4 | — |
| Q4: Definitely not | 1 | — |
| Q5: Always | 0 | — |
| Q5: Often | 3 | — |
| Q5: Sometimes | 8 | — |
| Q5: Rarely | 8 | — |
| Q5: Never | 3 | — |
| Q6: Much too full | 1 | — |
| Q6: Very full | 2 | — |
| Q6: Comfortably full | 17 | — |
| Q6: Slightly hungry | 2 | — |
| Q6: Very hungry | 0 | — |
| Q7: Extremely satisfied | 1 | — |
| Q7: Satisfied | 14 | — |
| Q7: Neither satisfied nor dissatisfied | 5 | — |
| Q7: Dissatisfied | 2 | — |
| Q7: Extremely dissatisfied | 0 | — |
Safety / tolerability / PK
4 endpointsSecondary/protocol endpoint
Mean Clearance of Albiglutide
Time frame:Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27
descriptive
Posted result
| Group | Value (mean), milliliters per hour | 95% CI |
|---|---|---|
| All Participants Receiving Any Dose of Albiglutide | 94.2 | 90.1 – 98.9 |
Secondary/protocol endpoint
Mean Volume of Distribution of Albiglutide
Time frame:Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27
descriptive
Posted result
| Group | Value (mean), Liters | 95% CI |
|---|---|---|
| All Participants Receiving Any Dose of Albiglutide | 16400 | 15600 – 17300 |
Secondary/protocol endpoint
Mean Absorption Rate of Albiglutide
Time frame:Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27
concentration, descriptive
Posted result
| Group | Value (mean), hour^-1 | 95% CI |
|---|---|---|
| All Participants Receiving Any Dose of Albiglutide | 0.0193 | 0.017 – 0.022 |
Secondary/protocol endpoint
Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG
Time frame:Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27
concentration, descriptive
Posted result
| Group | Value (mean), nanograms per milliliter | 95% CI |
|---|---|---|
| All Participants Receiving Any Dose of AlbiglutideHbA1c, Treatment-naïve group | 1140 | 483 – 2990 |
| HbA1c, Prior monotherapy group | 1230 | 403 – 3560 |
| FPG | 1970 | 950 – 5410 |
Publications (2)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Postgraduate medicine2014 Nov (month)PMID25387217doi:10.3810/pgm.2014.11.2836via clinicaltrials gov reference derived + pubmed nct search
- Diabetes care2009 Oct (month)PMID19592625doi:10.2337/dc09-0366via CT.gov background + pubmed nct search
Provenance
Sources
Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.